Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Scantibodies Laboratory, Inc. · Predicate Candidate Screening

19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

83 daysmedian FDA review time

294 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K060578	CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSI	Scantibodies Laboratory, Inc.	2006-08-30	177
K060420	MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINO	Scantibodies Laboratory, Inc.	2006-03-01	12
K060348	MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (I	Scantibodies Laboratory, Inc.	2006-02-27	17
K051888	TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSIO	Scantibodies Laboratory, Inc.	2005-10-18	98
K051810	WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COA	Scantibodies Laboratory, Inc.	2005-09-09	66
K051150	TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT	Scantibodies Laboratory, Inc.	2005-07-26	83
K051141	WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICM	Scantibodies Laboratory, Inc.	2005-07-26	83
K050748	ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011	Scantibodies Laboratory, Inc.	2005-05-20	59
K031534	CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY	Scantibodies Laboratory, Inc.	2003-07-30	75
K021032	ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3	Scantibodies Laboratory, Inc.	2002-06-03	66
K004038	TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODE	Scantibodies Laboratory, Inc.	2001-04-30	123
K001411	WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC	Scantibodies Laboratory, Inc.	2000-08-21	109
K974262	SYSCOS IDC - G, IDC, BSC, IDC - G	Scantibodies Laboratory, Inc.	1997-12-24	41
K962464	SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(C	Scantibodies Laboratory, Inc.	1996-10-08	105
K961043	SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD	Scantibodies Laboratory, Inc.	1996-05-06	53
K955812	SYSCON TURMOR MARKER CONTROL	Scantibodies Laboratory, Inc.	1996-03-12	77
K954247	SYSCON CONTROL ASSAYED & UNASSAYED	Scantibodies Laboratory, Inc.	1996-02-14	156
K944788	INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHN	Scantibodies Laboratory, Inc.	1995-07-19	294
K942647	COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI	Scantibodies Laboratory, Inc.	1995-07-12	404

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda